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Individualized Stereotactic Body Radiotherapy of Liver Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01239381
First received: June 14, 2010
Last updated: June 14, 2017
Last verified: June 2017
Results First Received: March 24, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Solid Tumor
Liver Metastases
Intervention: Radiation: Stereotactic body radiotherapy-proton

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SBRT-Proton

Stereotactic Body Radiation Therapy (SBRT) by proton radiation

Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks


Participant Flow:   Overall Study
    SBRT-Proton
STARTED   92 
COMPLETED   90 
NOT COMPLETED   2 
Protocol Violation                1 
Withdrawal by Subject                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients that were registered but did not start study therapy were not included in the analysis.

Reporting Groups
  Description
SBRT-Proton

SBRT by proton radiation

Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks


Baseline Measures
   SBRT-Proton 
Overall Participants Analyzed 
[Units: Participants]
 90 
Age 
[Units: Years]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 90 
   68 
 (34 to 89) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 90 
Female      33  36.7% 
Male      57  63.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   
Participants Analyzed 
[Units: Participants]
 90 
United States   90 
Primary Cancer Site 
[Units: Participants]
Count of Participants
 
Colorectal   
Participants Analyzed 
[Units: Participants]
 90 
Colorectal   35 
Pancreatic   
Participants Analyzed 
[Units: Participants]
 90 
Pancreatic   16 
Esophagogastric   
Participants Analyzed 
[Units: Participants]
 90 
Esophagogastric   12 
Hepatocellular   
Participants Analyzed 
[Units: Participants]
 90 
Hepatocellular   8 
Lung   
Participants Analyzed 
[Units: Participants]
 90 
Lung   5 
Gallbladder   
Participants Analyzed 
[Units: Participants]
 90 
Gallbladder   3 
Breast   
Participants Analyzed 
[Units: Participants]
 90 
Breast   3 
Small Bowel or Duodenal   
Participants Analyzed 
[Units: Participants]
 90 
Small Bowel or Duodenal   3 
Anal   
Participants Analyzed 
[Units: Participants]
 90 
Anal   2 
Head and Neck   
Participants Analyzed 
[Units: Participants]
 90 
Head and Neck   2 
Prostate   
Participants Analyzed 
[Units: Participants]
 90 
Prostate   1 
Number of Tumors 
[Units: Participants]
Count of Participants
 
1 Tumor   
Participants Analyzed 
[Units: Participants]
 90 
1 Tumor   54 
2 Tumors   
Participants Analyzed 
[Units: Participants]
 90 
2 Tumors   21 
3 Tumors   
Participants Analyzed 
[Units: Participants]
 90 
3 Tumors   10 
4 Tumors   
Participants Analyzed 
[Units: Participants]
 90 
4 Tumors   5 
Median Tumor Size [1] 
[Units: Centimeters (cm)]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 90 
   2.55 
 (0.48 to 11.9) 
[1] Median Tumor size among the 142 tumors analyzed
Categorical Tumor size [1] 
[Units: Participants]
Count of Participants
 
≤ 5 cm   
Participants Analyzed 
[Units: Participants]
 88 
≤ 5 cm   50 
> 5 cm   
Participants Analyzed 
[Units: Participants]
 88 
> 5 cm   31 
> 10 cm   
Participants Analyzed 
[Units: Participants]
 88 
> 10 cm   7 
[1] 88 participants with complete tumor size data


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Local Control Rate   [ Time Frame: 1 year ]

2.  Secondary:   Median Follow-up Time   [ Time Frame: 1 year ]

3.  Secondary:   Median Overall Survival   [ Time Frame: 2 years ]

4.  Secondary:   Median Progression Free Survival   [ Time Frame: 1 years ]

5.  Secondary:   2-year Local Control Rate   [ Time Frame: 2 years ]

6.  Secondary:   1 Year Local Control Rate Among Participants With Colorectal Cancer   [ Time Frame: 1 year ]

7.  Secondary:   Median Survival Among Participants With Colorectal Cancer   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Theodore S Hong, MD, physician radiation oncology
Organization: Massachusetts General Hospital
phone: 617-726-6050
e-mail: TSHONG1@mgh.harvard.edu



Responsible Party: Theodore Sunki Hong, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01239381     History of Changes
Other Study ID Numbers: 10-139
Other ( Other Grant/Funding Number: program income earned on C06 CA059267 )
Study First Received: June 14, 2010
Results First Received: March 24, 2017
Last Updated: June 14, 2017